Department: Research and Development
Reports To: R&D Manager
FLSA Status: Non-Exempt
Employee Type: Full-Time
Hours: 40 hours/week Monday - Friday 8:00 am – 5:00 pm (30 minutes for lunch and 30 minutes for a break). Nights and weekends can be approved by manager.
SummaryThe R&D Scientist II provides technical and scientific leadership to support new product development, troubleshooting and optimization of process and analytical methods, and technical communications with customers and suppliers. Identifies and implements new methods, equipment, and technologies. Effectively performs the following duties:
Essential Duties & Responsibilities- New product development with the assistance of more experienced R&D Scientists: evaluates published literature and provides technical and economic analysis of product feasibility, performs experimental work to develop, optimize, scale up, and validate new production or analytical procedures, creates documents (SOPs, protocols, reports) needed for implementation of the new processes, and assists in scale up and transfer of new processes to other departments.
- Learns and performs design control procedures and documentation.
- Assists production and other departments with troubleshooting problematic production issues, and assists with production scale up of new and old processes.
- Implements scale up of new processes and potential scale up for current processes.
- Identification and implementation of new technology: reads scientific and trade journals, communicates with suppliers and sources of new technology, attends seminars, webinars, and other presentations to identify new methods, equipment, and technologies.
- Assists other employees as necessary. Examples include protein purification and analysis, calibration and preventive maintenance of equipment and facility, and filling of orders.
- Assures that all work is properly recorded and signed off in lab notebooks, batch records, worksheets, or other appropriate documents.
Other Duties
- Complies with all safety protocols.
- Performs other assigned duties.
Qualifications
To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function.
Education / ExperienceB.A. in a related field from an accredited college or university plus at least five years’ experience or master’s degree with three years’ experience, or equivalent combination of education and experience.
Physical DemandsThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is frequently required to stand, walk, use hands, reach with hands and arms, talk and hear. The employee is occasionally required to sit; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to adjust focus. The employee may be required to wear personal protective equipment such as gloves, a lab coat, safety glasses or goggles, a face shield, a respirator or other equipment necessary for safe performance of the job requirements. The employee may be required to wear gloves, gowns, hairnets and other clothing in order to protect product integrity.
Training RequiredISO Regulations, QSR (cGMP) Regulations, New Employee Orientation, Blood-borne Pathogens Regulation, HIPAA Regulations, QAPs, SSOPs and SOPs, Relevant equipment, methods and batch records. Additional training provided as needed.
Reasoning AbilityAbility to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
CommunicationAbility to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.
Math AbilityAbility to calculate figures and amounts such as discounts, interest, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry. Able to use routine chemistry formulas.
Equipment UsedBalances, Centrifuges, Chromatography columns, pumps, fraction collectors, and monitors; Clinical chemistry analyzer, Filtration and ultra‑filtration equipment; Gel electrophoresis and blotting equipment; Laminar flow hood; Lyophilizers; Mixers; Multiwell plate reader; Personal computer; pH and conductivity meters; Pipettes; Tissue homogenizers, grinders, and blenders; UV‑VIS spectrophotometers and other equipment as needed or directed.
Work EnvironmentThe work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The employee is frequently exposed to wet or humid conditions (nonweather); work near moving mechanical parts; fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to work in high, precarious places; outdoor weather conditions; extreme cold (non‑weather); extreme heat (non‑weather); risk of electrical shock and vibration. The noise level in the work environment is moderate.
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